BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

    K Number: K181563 · Decision Sep 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    6
    Review Days
    104

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    Basic Information

    Device Name
    The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
    K Number
    K181563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Scientific, LLC
    Date Received
    June 14, 2018
    Decision Date
    September 26, 2018
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQY Catheter, Percutaneous

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    Other Clearances by Access Scientific, LLC

    K Number Device Name
    K183066 The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
    K182243 The CVC WAND Safety Introducer with Valved Peelable Sheath
    K162322 the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
    K131148 THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
    K131300 THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER